Table 3.
Adverse reactions occurring in ≥5% of patients or healthy volunteers during the pivotal phase III trial8
| Side effect | Placebo (n = 69) N (%) | 20 mg (n = 37) N (%) | 40 mga(n = 315) N (%) |
|---|---|---|---|
| Blood and lymphatic system disorders | |||
| Anemia NOS | 2 (3%) | 2 (5%) | 18 (6%) |
| Cardiac disorders | |||
| Atrial fibrillation | 0 (0%) | 2 (5%) | 7 (2%) |
| Gastrointestinal disorders | |||
| Constipation | 2 (3%) | 3 (8%) | 20 (6%) |
| Diarrhea NOS | 0 (0%) | 0 (0%) | 23 (7%) |
| Nausea | 3 (4%) | 1 (3%) | 17 (5%) |
| Vomiting NOS | 0 (0%) | 2 (5%) | 23 (7%) |
| General disorders and administration site conditions | |||
| Edema peripheral | 1 (1%) | 1 (3%) | 24 (8%) |
| Infusion site erythema | 0 (0%) | 0 (0%) | 18 (6%) |
| Infusion site pain | 1 (1%) | 0 (0%) | 16 (5%) |
| Infusion site phlebitis | 1 (1%) | 19 (51%) | 102 (32%) |
| Infusion site reaction | 0 (0%) | 8 (22%) | 61 (19%) |
| Pyrexia | 0 (0%) | 4 (11%) | 15 (5%) |
| Thirst | 1 (1%) | 1 (3%) | 19 (6%) |
| Infections | |||
| Pneumonia NOS | 0 (0%) | 2 (5%) | 7 (2%) |
| Urinary tract infection NOS | 2 (3%) | 2 (5%) | 14 (4%) |
| Injury, poisoning and procedural complications | |||
| Post-procedural diarrhea | 0 (0%) | 2 (5%) | 0 (0%) |
| Investigations | |||
| ECG ST segment depression | 0 (0%) | 2 (5%) | 0 (0%) |
| Metabolism and nutrition disorders | |||
| Hypokalemia | 2 (3%) | 8 (22%) | 30 (10%) |
| Hypomagnesemia | 0 (0%) | 2 (5%) | 6 (2%) |
| Hyponatremia | 1 (1%) | 3 (8%) | 20 (6%) |
| Nervous system disorders | |||
| Headache | 2 (3%) | 3 (8%) | 32 (10%) |
| Psychiatric disorders | |||
| Confusional state | 2 (3%) | 0 (0%) | 16 (5%) |
| Insomnia | 0 (0%) | 2 (5%) | 12 (4%) |
| Respiratory, thoracic and mediastinal disorders | |||
| Pharyngolaryngeal pain | 3 (4%) | 2 (5%) | 3 (1%) |
| Skin and subcutaneous tissue disorders | |||
| Pruritus | 0 (0%) | 2 (5%) | 2 (1%) |
| Vascular disorders | |||
| Hypertension NOS | 0 (0%) | 3 (8%) | 20 (6%) |
| Hypotension NOS | 2 (3%) | 3 (8%) | 16 (5%) |
| Orthostatic hypotension | 0 (0%) | 5 (14%) | 18 (6%) |
Notes:
a
Although an intravenous dose of conivaptan 80 mg/day was also studied, it was associated with a higher incidence of infusion site reactions and a higher rate of discontinuation due to adverse events than the 40 mg/day dose. The maximum FDA-approved daily intravenous dose of conivaptan (following the loading dose) is 40 mg/day.
Abbreviations: ECG, electrocardiogram; NOS, not otherwise specified.