Table 4.
List of nonserious adverse events
| Adverse Event Type | ORBCEL-M Events, n (Participants, n) |
Placebo Events, n (Participants, n) |
|---|---|---|
| Left bundle block | 2 (2) | — |
| First-degree atrioventricular block | 1 (1) | — |
| Inferior Q wave | 1 (1) | — |
| Ejection systolic murmur | 1 (1) | — |
| Chest pain | 2 (2) | — |
| Fatigue | 1 (1) | — |
| Asthenia | 1 (1) | — |
| Increased edema | 4 (1) | — |
| Hypoglycemia | 1 (1) | — |
| Eye disorder | — | 1 (1) |
| Cataract | 1 (1) | — |
| Diarrhea | 3 (3) | 1 (1) |
| Heartburn | 1 (1) | — |
| Vomiting associated with ileus | 1 (1) | — |
| Hemorrhoids | — | 1 (1) |
| Fever of unknown origin | — | 1 (1) |
| Flu-like syndrome | 1 (1) | — |
| Ankle swelling | 1 (1) | — |
| Bruised ribs | 1 (1) | — |
| Stenosing tenosynovitis | 1 (1) | — |
| Laceration to left shin | 1 (1) | — |
| Left knee swelling | 1 (1) | — |
| Traumatic injury left foot | — | 1 (1) |
| Fall | 1 (1) | — |
| Meralgia paresthetica | 1 (1) | — |
| Wound infection | — | 1 (1) |
| Pain associated with SAE hip fracture | 1 (1) | — |
| Pain right heel | — | 1 (1) |
| Knee pain | 1 (1) | — |
| Painful shoulder | 1 (1) | — |
| Headache | 1 (1) | — |
| Low mood | 1 (1) | — |
| Memory impairment | 1 (1) | — |
| Disoriented | 1 (1) | — |
| Cough | 2 (2) | 1 (1) |
| Hoarse | 1 (1) | — |
| Obstructive sleep apnea | — | 1 (1) |
| Abdominal bruising | — | 1 (1) |
| Perianal dermatitis | — | 1 (1) |
| Pressure sore (sacral) | 1 (1) | — |
| Tingling in limb peripheries | 1 (1) | — |
| Benign prostatic hyperplasia | 1 (1) | — |
| Secondary hyperparathyroidism | 1 (1) | — |
| Erythroderma | — | 1 (1) |
| Urinary tract infection | 1 (1) | — |
| AKI | 1 (1) | — |
| Hypereosinophilia | 1 (1) | — |
| Total | 45 (11) | 12 (4) |
SAE, serious adverse event.