| . | Visbiome ES (n=47), No. (%) . | Placebo (n=43), No. (%) . | ||||
|---|---|---|---|---|---|---|
| Overall . | Grade 1–2 . | Grade ≥3 . | Overall . | Grade 1–2 . | Grade ≥3 . | |
| Totala | 17 (36) | 10 (22) | 7 (15) | 8 (19) | 4 (9) | 4(9) |
| GI disorder | 5 (11) | 4 (8) | 1 (2) | 2 (5) | 1 (2) | 1 (2) |
| Infections & infestations | 4 (9) | 3 (6) | 1 (2) | 2 (5) | 1 (2) | 1 (2) |
| Musculoskeletal | 4 (9) | 3 (6) | 1 (2) | 0 | 0 | 0 |
| Metabolic/nutritional | 1 (2) | 1 (2) | 0 | 1 (2) | 1 (2) | 0 |
| Neoplasm | 1 (2) | 0 | 1 (2) | 1 (2) | 1 (2) | 0 |
| Renal/urinary | 1 (2) | 1 (2) | 0 | 0 | 0 | 0 |
| Psychiatric | 0 | 0 | 0 | 1 (2) | 1 (2) | 0 |
| Respiratory/thoracic | 2 (4) | 1 (2) | 1(2) | 0 | 0 | 0 |
| Skin/soft tissue | 0 | 0 | 0 | 1 (2) | 1 (2) | 0 |
| General disorders | 1 (2) | 1 (2) | 0 | 1 (2) | 1 (2) | 0 |
| Injury/poisoning/procedural | 2 (4) | 1 (2) | 1(2) | 2 (5) | 0 | 2 (5) |
| . | Visbiome ES (n=47), No. (%) . | Placebo (n=43), No. (%) . | ||||
|---|---|---|---|---|---|---|
| Overall . | Grade 1–2 . | Grade ≥3 . | Overall . | Grade 1–2 . | Grade ≥3 . | |
| Totala | 17 (36) | 10 (22) | 7 (15) | 8 (19) | 4 (9) | 4(9) |
| GI disorder | 5 (11) | 4 (8) | 1 (2) | 2 (5) | 1 (2) | 1 (2) |
| Infections & infestations | 4 (9) | 3 (6) | 1 (2) | 2 (5) | 1 (2) | 1 (2) |
| Musculoskeletal | 4 (9) | 3 (6) | 1 (2) | 0 | 0 | 0 |
| Metabolic/nutritional | 1 (2) | 1 (2) | 0 | 1 (2) | 1 (2) | 0 |
| Neoplasm | 1 (2) | 0 | 1 (2) | 1 (2) | 1 (2) | 0 |
| Renal/urinary | 1 (2) | 1 (2) | 0 | 0 | 0 | 0 |
| Psychiatric | 0 | 0 | 0 | 1 (2) | 1 (2) | 0 |
| Respiratory/thoracic | 2 (4) | 1 (2) | 1(2) | 0 | 0 | 0 |
| Skin/soft tissue | 0 | 0 | 0 | 1 (2) | 1 (2) | 0 |
| General disorders | 1 (2) | 1 (2) | 0 | 1 (2) | 1 (2) | 0 |
| Injury/poisoning/procedural | 2 (4) | 1 (2) | 1(2) | 2 (5) | 0 | 2 (5) |
Abbreviations: AE, adverse event; ES, Extra Strength; GI, gastrointestinal.
Any AE: 17 (36%) vs 8 (19%); P=.098 by Fisher exact test.
| . | Visbiome ES (n=47), No. (%) . | Placebo (n=43), No. (%) . | ||||
|---|---|---|---|---|---|---|
| Overall . | Grade 1–2 . | Grade ≥3 . | Overall . | Grade 1–2 . | Grade ≥3 . | |
| Totala | 17 (36) | 10 (22) | 7 (15) | 8 (19) | 4 (9) | 4(9) |
| GI disorder | 5 (11) | 4 (8) | 1 (2) | 2 (5) | 1 (2) | 1 (2) |
| Infections & infestations | 4 (9) | 3 (6) | 1 (2) | 2 (5) | 1 (2) | 1 (2) |
| Musculoskeletal | 4 (9) | 3 (6) | 1 (2) | 0 | 0 | 0 |
| Metabolic/nutritional | 1 (2) | 1 (2) | 0 | 1 (2) | 1 (2) | 0 |
| Neoplasm | 1 (2) | 0 | 1 (2) | 1 (2) | 1 (2) | 0 |
| Renal/urinary | 1 (2) | 1 (2) | 0 | 0 | 0 | 0 |
| Psychiatric | 0 | 0 | 0 | 1 (2) | 1 (2) | 0 |
| Respiratory/thoracic | 2 (4) | 1 (2) | 1(2) | 0 | 0 | 0 |
| Skin/soft tissue | 0 | 0 | 0 | 1 (2) | 1 (2) | 0 |
| General disorders | 1 (2) | 1 (2) | 0 | 1 (2) | 1 (2) | 0 |
| Injury/poisoning/procedural | 2 (4) | 1 (2) | 1(2) | 2 (5) | 0 | 2 (5) |
| . | Visbiome ES (n=47), No. (%) . | Placebo (n=43), No. (%) . | ||||
|---|---|---|---|---|---|---|
| Overall . | Grade 1–2 . | Grade ≥3 . | Overall . | Grade 1–2 . | Grade ≥3 . | |
| Totala | 17 (36) | 10 (22) | 7 (15) | 8 (19) | 4 (9) | 4(9) |
| GI disorder | 5 (11) | 4 (8) | 1 (2) | 2 (5) | 1 (2) | 1 (2) |
| Infections & infestations | 4 (9) | 3 (6) | 1 (2) | 2 (5) | 1 (2) | 1 (2) |
| Musculoskeletal | 4 (9) | 3 (6) | 1 (2) | 0 | 0 | 0 |
| Metabolic/nutritional | 1 (2) | 1 (2) | 0 | 1 (2) | 1 (2) | 0 |
| Neoplasm | 1 (2) | 0 | 1 (2) | 1 (2) | 1 (2) | 0 |
| Renal/urinary | 1 (2) | 1 (2) | 0 | 0 | 0 | 0 |
| Psychiatric | 0 | 0 | 0 | 1 (2) | 1 (2) | 0 |
| Respiratory/thoracic | 2 (4) | 1 (2) | 1(2) | 0 | 0 | 0 |
| Skin/soft tissue | 0 | 0 | 0 | 1 (2) | 1 (2) | 0 |
| General disorders | 1 (2) | 1 (2) | 0 | 1 (2) | 1 (2) | 0 |
| Injury/poisoning/procedural | 2 (4) | 1 (2) | 1(2) | 2 (5) | 0 | 2 (5) |
Abbreviations: AE, adverse event; ES, Extra Strength; GI, gastrointestinal.
Any AE: 17 (36%) vs 8 (19%); P=.098 by Fisher exact test.
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