Safety Evaluation up to Late Follow-Up Visit, 6–7 Weeks from Randomization (Safety Population)
| . | Patients, No. (%)a . | |
|---|---|---|
| Ceftazidime-Avibactam + Metronidazole (n = 529) . | Meropenem (n = 529) . | |
| Summary | ||
| Any AEb | 243 (45.9) | 227 (42.9) |
| Any AE of severe intensity | 30 (5.7) | 36 (6.8) |
| Any serious AE | 42 (7.9) | 40 (7.6) |
| Any AE leading to discontinuation | 14 (2.6) | 7 (1.3) |
| Any AE leading to death | 13 (2.5) | 8 (1.5) |
| AEs in ≥2% of patients in either treatment group by system organ class/preferred termc | ||
| Infections and infestations | ||
| Wound infection | 13 (2.5) | 11 (2.1) |
| Blood and lymphatic system disorders | ||
| Anemia | 11 (2.1) | 9 (1.7) |
| Nervous system disorders | ||
| Headache | 15 (2.8) | 9 (1.7) |
| Vascular disorders | ||
| Hypertension | 15 (2.8) | 24 (4.5) |
| Hypotension | 12 (2.3) | 12 (2.3) |
| Phlebitis | 10 (1.9) | 11 (2.1) |
| Respiratory disorders | ||
| Cough | 11 (2.1) | 13 (2.5) |
| Gastrointestinal disorders | ||
| Diarrhead | 40 (7.6) | 17 (3.2) |
| Nausea | 36 (6.8) | 24 (4.5) |
| Vomiting | 24 (4.5) | 10 (1.9) |
| Abdominal distension | 10 (1.9) | 11 (2.1) |
| Constipation | 8 (1.5) | 20 (3.8) |
| General disorders | ||
| Pyrexia | 24 (4.5) | 24 (4.5) |
| Asthenia | 10 (1·9) | 12 (2·3) |
| Safety topicse | ||
| Liver disorder | 11 (2.1) | 8 (1.5) |
| Diarrhea | 40 (7.6) | 18 (3.4) |
| Hypersensitivity/anaphylaxis disorder | 23 (4.3) | 16 (3.0) |
| Hematological disorder | 16 (3.0) | 15 (2.8) |
| Renal disorder | 12 (2.3) | 3 (0.6) |
| . | Patients, No. (%)a . | |
|---|---|---|
| Ceftazidime-Avibactam + Metronidazole (n = 529) . | Meropenem (n = 529) . | |
| Summary | ||
| Any AEb | 243 (45.9) | 227 (42.9) |
| Any AE of severe intensity | 30 (5.7) | 36 (6.8) |
| Any serious AE | 42 (7.9) | 40 (7.6) |
| Any AE leading to discontinuation | 14 (2.6) | 7 (1.3) |
| Any AE leading to death | 13 (2.5) | 8 (1.5) |
| AEs in ≥2% of patients in either treatment group by system organ class/preferred termc | ||
| Infections and infestations | ||
| Wound infection | 13 (2.5) | 11 (2.1) |
| Blood and lymphatic system disorders | ||
| Anemia | 11 (2.1) | 9 (1.7) |
| Nervous system disorders | ||
| Headache | 15 (2.8) | 9 (1.7) |
| Vascular disorders | ||
| Hypertension | 15 (2.8) | 24 (4.5) |
| Hypotension | 12 (2.3) | 12 (2.3) |
| Phlebitis | 10 (1.9) | 11 (2.1) |
| Respiratory disorders | ||
| Cough | 11 (2.1) | 13 (2.5) |
| Gastrointestinal disorders | ||
| Diarrhead | 40 (7.6) | 17 (3.2) |
| Nausea | 36 (6.8) | 24 (4.5) |
| Vomiting | 24 (4.5) | 10 (1.9) |
| Abdominal distension | 10 (1.9) | 11 (2.1) |
| Constipation | 8 (1.5) | 20 (3.8) |
| General disorders | ||
| Pyrexia | 24 (4.5) | 24 (4.5) |
| Asthenia | 10 (1·9) | 12 (2·3) |
| Safety topicse | ||
| Liver disorder | 11 (2.1) | 8 (1.5) |
| Diarrhea | 40 (7.6) | 18 (3.4) |
| Hypersensitivity/anaphylaxis disorder | 23 (4.3) | 16 (3.0) |
| Hematological disorder | 16 (3.0) | 15 (2.8) |
| Renal disorder | 12 (2.3) | 3 (0.6) |
Abbreviation: AE, adverse event.
a Patients with multiple AEs are counted once for each system organ class and/or preferred term.
b Each patient is counted only once within a treatment group in this overall summary.
c AEs are sorted by system organ class in international order and by preferred term in decreasing order of frequency in patients treated with ceftazidime-avibactam plus metronidazole.
d There was 1 toxin-positive case of Clostridium difficile enterocolitis in each treatment group, confirmed by a local laboratory. Both cases were considered nonserious and moderate in intensity.
e Each safety topic represents the aggregate of a group of preidentified relevant AE preferred terms based on those from previous a phase 2 study of ceftazidime-avibactam in complicated intra-abdominal infection.
Safety Evaluation up to Late Follow-Up Visit, 6–7 Weeks from Randomization (Safety Population)
| . | Patients, No. (%)a . | |
|---|---|---|
| Ceftazidime-Avibactam + Metronidazole (n = 529) . | Meropenem (n = 529) . | |
| Summary | ||
| Any AEb | 243 (45.9) | 227 (42.9) |
| Any AE of severe intensity | 30 (5.7) | 36 (6.8) |
| Any serious AE | 42 (7.9) | 40 (7.6) |
| Any AE leading to discontinuation | 14 (2.6) | 7 (1.3) |
| Any AE leading to death | 13 (2.5) | 8 (1.5) |
| AEs in ≥2% of patients in either treatment group by system organ class/preferred termc | ||
| Infections and infestations | ||
| Wound infection | 13 (2.5) | 11 (2.1) |
| Blood and lymphatic system disorders | ||
| Anemia | 11 (2.1) | 9 (1.7) |
| Nervous system disorders | ||
| Headache | 15 (2.8) | 9 (1.7) |
| Vascular disorders | ||
| Hypertension | 15 (2.8) | 24 (4.5) |
| Hypotension | 12 (2.3) | 12 (2.3) |
| Phlebitis | 10 (1.9) | 11 (2.1) |
| Respiratory disorders | ||
| Cough | 11 (2.1) | 13 (2.5) |
| Gastrointestinal disorders | ||
| Diarrhead | 40 (7.6) | 17 (3.2) |
| Nausea | 36 (6.8) | 24 (4.5) |
| Vomiting | 24 (4.5) | 10 (1.9) |
| Abdominal distension | 10 (1.9) | 11 (2.1) |
| Constipation | 8 (1.5) | 20 (3.8) |
| General disorders | ||
| Pyrexia | 24 (4.5) | 24 (4.5) |
| Asthenia | 10 (1·9) | 12 (2·3) |
| Safety topicse | ||
| Liver disorder | 11 (2.1) | 8 (1.5) |
| Diarrhea | 40 (7.6) | 18 (3.4) |
| Hypersensitivity/anaphylaxis disorder | 23 (4.3) | 16 (3.0) |
| Hematological disorder | 16 (3.0) | 15 (2.8) |
| Renal disorder | 12 (2.3) | 3 (0.6) |
| . | Patients, No. (%)a . | |
|---|---|---|
| Ceftazidime-Avibactam + Metronidazole (n = 529) . | Meropenem (n = 529) . | |
| Summary | ||
| Any AEb | 243 (45.9) | 227 (42.9) |
| Any AE of severe intensity | 30 (5.7) | 36 (6.8) |
| Any serious AE | 42 (7.9) | 40 (7.6) |
| Any AE leading to discontinuation | 14 (2.6) | 7 (1.3) |
| Any AE leading to death | 13 (2.5) | 8 (1.5) |
| AEs in ≥2% of patients in either treatment group by system organ class/preferred termc | ||
| Infections and infestations | ||
| Wound infection | 13 (2.5) | 11 (2.1) |
| Blood and lymphatic system disorders | ||
| Anemia | 11 (2.1) | 9 (1.7) |
| Nervous system disorders | ||
| Headache | 15 (2.8) | 9 (1.7) |
| Vascular disorders | ||
| Hypertension | 15 (2.8) | 24 (4.5) |
| Hypotension | 12 (2.3) | 12 (2.3) |
| Phlebitis | 10 (1.9) | 11 (2.1) |
| Respiratory disorders | ||
| Cough | 11 (2.1) | 13 (2.5) |
| Gastrointestinal disorders | ||
| Diarrhead | 40 (7.6) | 17 (3.2) |
| Nausea | 36 (6.8) | 24 (4.5) |
| Vomiting | 24 (4.5) | 10 (1.9) |
| Abdominal distension | 10 (1.9) | 11 (2.1) |
| Constipation | 8 (1.5) | 20 (3.8) |
| General disorders | ||
| Pyrexia | 24 (4.5) | 24 (4.5) |
| Asthenia | 10 (1·9) | 12 (2·3) |
| Safety topicse | ||
| Liver disorder | 11 (2.1) | 8 (1.5) |
| Diarrhea | 40 (7.6) | 18 (3.4) |
| Hypersensitivity/anaphylaxis disorder | 23 (4.3) | 16 (3.0) |
| Hematological disorder | 16 (3.0) | 15 (2.8) |
| Renal disorder | 12 (2.3) | 3 (0.6) |
Abbreviation: AE, adverse event.
a Patients with multiple AEs are counted once for each system organ class and/or preferred term.
b Each patient is counted only once within a treatment group in this overall summary.
c AEs are sorted by system organ class in international order and by preferred term in decreasing order of frequency in patients treated with ceftazidime-avibactam plus metronidazole.
d There was 1 toxin-positive case of Clostridium difficile enterocolitis in each treatment group, confirmed by a local laboratory. Both cases were considered nonserious and moderate in intensity.
e Each safety topic represents the aggregate of a group of preidentified relevant AE preferred terms based on those from previous a phase 2 study of ceftazidime-avibactam in complicated intra-abdominal infection.
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