Table 2.
Baseline Medical Conditions Reported by Safety Substudy Participants by Medical Dictionary for Regulatory Activities System Organ Class (n = 440)
| MedDRA SOC and PTa | No. | (%) |
|---|---|---|
| Congenital, familial, and genetic disorders | 4 | (0.9) |
| Eye disorders | 2 | (0.4) |
| Gastrointestinal disorders | 26 | (5.9) |
| Gastric ulcer | 13 | (3.0) |
| Peptic ulcer | 12 | (2.7) |
| Other | 1 | (0.2) |
| General disorders and administration site conditions | 10 | (2.3) |
| Ulcerb | 8 | (1.8) |
| Other | 2 | (0.4) |
| Hepatobiliary disorders | 1 | (0.2) |
| Immune system disorders | 62 | (14.1) |
| Drug hypersensitivity | 51 | (11.6) |
| Food allergy | 6 | (1.4) |
| Other | 5 | (1.1) |
| Infections and infestationsc | 13 | (3.0) |
| Malaria | 6 | (1.4) |
| Typhoid fever | 5 | (1.1) |
| Other | 3 | (0.6) |
| Injury, poisoning, and procedural complications | 3 | (0.7) |
| Investigations | 1 | (0.2) |
| Musculoskeletal and connective tissue disordersc | 39 | (8.9) |
| Arthralgia | 17 | (3.9) |
| Arthropathy | 12 | (2.7) |
| Other | 12 | (2.7) |
| Nervous system disorders | 2 | (0.5) |
| Respiratory, thoracic, and mediastinal disorders | 3 | (0.7) |
| Surgical and medical procedures | 1 | (0.2) |
| Vascular disorders | 1 | (0.2) |
Abbreviations: MedDRA, Medical Dictionary for Regulatory Activities; PT, preferred term; SOC, system organ class.
aWithin each SOC, individual PTs reported by ≥1% of substudy participants are listed.
bThe organ system affected was not documented.
cThe sum of the PTs is greater than the total for the SOC because some participants in this SOC reported >1 PT.