Post-ADR Status of iguratimod administration by type of ADR (liver dysfunction).
| Post-ADR status | |||||
| Type of ADR (duplicate entries) | All patients | Continuation | Discontinuation | ||
| (N = 259) | (n = 110) | (n = 149) | |||
| Number and proportion (%) of patients | |||||
| Hepatobiliary disorders | 167 | 61 | 55% | 106 | 71% |
| Abnormal liver function | 135 | 52 | 47% | 83 | 56% |
| Acute hepatitis | 1 | 0 | 0% | 1 | 1% |
| Liver disorder | 36 | 13 | 12% | 23 | 15% |
| Drug-related liver disorder | 3 | 0 | 0% | 3 | 2% |
| Laboratory tests | 94 | 51 | 46% | 43 | 29% |
| ALT increased | 48 | 27 | 25% | 21 | 14% |
| AST increased | 40 | 22 | 20% | 18 | 12% |
| Blood bilirubin increased | 2 | 2 | 2% | 0 | 0% |
| Gamma-GTP increased | 18 | 9 | 8% | 9 | 6% |
| ALP increased | 15 | 9 | 8% | 6 | 4% |
| Liver function test abnormalitiesa | 23 | 9 | 8% | 14 | 9% |
| Hepatitis B DNA increased | 1 | 1 | 1% | 0 | 0% |
| Post-ADR status | |||||
| Type of ADR (duplicate entries) | All patients | Continuation | Discontinuation | ||
| (N = 259) | (n = 110) | (n = 149) | |||
| Number and proportion (%) of patients | |||||
| Hepatobiliary disorders | 167 | 61 | 55% | 106 | 71% |
| Abnormal liver function | 135 | 52 | 47% | 83 | 56% |
| Acute hepatitis | 1 | 0 | 0% | 1 | 1% |
| Liver disorder | 36 | 13 | 12% | 23 | 15% |
| Drug-related liver disorder | 3 | 0 | 0% | 3 | 2% |
| Laboratory tests | 94 | 51 | 46% | 43 | 29% |
| ALT increased | 48 | 27 | 25% | 21 | 14% |
| AST increased | 40 | 22 | 20% | 18 | 12% |
| Blood bilirubin increased | 2 | 2 | 2% | 0 | 0% |
| Gamma-GTP increased | 18 | 9 | 8% | 9 | 6% |
| ALP increased | 15 | 9 | 8% | 6 | 4% |
| Liver function test abnormalitiesa | 23 | 9 | 8% | 14 | 9% |
| Hepatitis B DNA increased | 1 | 1 | 1% | 0 | 0% |
Status of post-ADR iguratimod treatment continuation for each MedDRA PT. The composition ratio shows the percentage of continuations and discontinuations relative to all patients.
aLiver function test abnormalities contain the following preferred terms: liver function tests abnormal, laboratory tests abnormal, transaminase elevated, liver enzymes elevated, liver enzymes abnormal and liver function test values elevated.
ADR: adverse drug reaction; ALT: alanine aminotransferase; AST: aspartate aminotransferase; GTP: glutamyl transpeptidase; ALP: alkaline phosphatase.
Post-ADR Status of iguratimod administration by type of ADR (liver dysfunction).
| Post-ADR status | |||||
| Type of ADR (duplicate entries) | All patients | Continuation | Discontinuation | ||
| (N = 259) | (n = 110) | (n = 149) | |||
| Number and proportion (%) of patients | |||||
| Hepatobiliary disorders | 167 | 61 | 55% | 106 | 71% |
| Abnormal liver function | 135 | 52 | 47% | 83 | 56% |
| Acute hepatitis | 1 | 0 | 0% | 1 | 1% |
| Liver disorder | 36 | 13 | 12% | 23 | 15% |
| Drug-related liver disorder | 3 | 0 | 0% | 3 | 2% |
| Laboratory tests | 94 | 51 | 46% | 43 | 29% |
| ALT increased | 48 | 27 | 25% | 21 | 14% |
| AST increased | 40 | 22 | 20% | 18 | 12% |
| Blood bilirubin increased | 2 | 2 | 2% | 0 | 0% |
| Gamma-GTP increased | 18 | 9 | 8% | 9 | 6% |
| ALP increased | 15 | 9 | 8% | 6 | 4% |
| Liver function test abnormalitiesa | 23 | 9 | 8% | 14 | 9% |
| Hepatitis B DNA increased | 1 | 1 | 1% | 0 | 0% |
| Post-ADR status | |||||
| Type of ADR (duplicate entries) | All patients | Continuation | Discontinuation | ||
| (N = 259) | (n = 110) | (n = 149) | |||
| Number and proportion (%) of patients | |||||
| Hepatobiliary disorders | 167 | 61 | 55% | 106 | 71% |
| Abnormal liver function | 135 | 52 | 47% | 83 | 56% |
| Acute hepatitis | 1 | 0 | 0% | 1 | 1% |
| Liver disorder | 36 | 13 | 12% | 23 | 15% |
| Drug-related liver disorder | 3 | 0 | 0% | 3 | 2% |
| Laboratory tests | 94 | 51 | 46% | 43 | 29% |
| ALT increased | 48 | 27 | 25% | 21 | 14% |
| AST increased | 40 | 22 | 20% | 18 | 12% |
| Blood bilirubin increased | 2 | 2 | 2% | 0 | 0% |
| Gamma-GTP increased | 18 | 9 | 8% | 9 | 6% |
| ALP increased | 15 | 9 | 8% | 6 | 4% |
| Liver function test abnormalitiesa | 23 | 9 | 8% | 14 | 9% |
| Hepatitis B DNA increased | 1 | 1 | 1% | 0 | 0% |
Status of post-ADR iguratimod treatment continuation for each MedDRA PT. The composition ratio shows the percentage of continuations and discontinuations relative to all patients.
aLiver function test abnormalities contain the following preferred terms: liver function tests abnormal, laboratory tests abnormal, transaminase elevated, liver enzymes elevated, liver enzymes abnormal and liver function test values elevated.
ADR: adverse drug reaction; ALT: alanine aminotransferase; AST: aspartate aminotransferase; GTP: glutamyl transpeptidase; ALP: alkaline phosphatase.
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