Table 3.
Adverse Effects and Serious Adverse Events by Treatment Arm
| Treatment Arma |
|||
|---|---|---|---|
| Variable | Standard (8 wk) |
Extended (24 wk) |
Maintenance (52 wk) |
| No. of serious adverse eventsb | |||
|
| |||
| Weeks 1-8 | 1 | 0 | 3 |
|
| |||
| Weeks 9-24 | 0 | 1 | 3 |
|
| |||
| Weeks 25-52 | 3 | 1 | 2 |
|
| |||
| Week 4 Adverse Effects | |||
|
| |||
| No. of participants | 165 | 148 | 146 |
|
| |||
| Summary score, mean (SD)c | 5.3 (6.0) | 4.5 (5.1) | 5.0 (4.9) |
|
| |||
| Frequency of severe adverse effects | 21 (12.7) | 22 (14.9) | 16 (11.0) |
|
| |||
| Headached | 2 (1.2) | 5 (3.4) | 0 |
|
| |||
| Nausea | 2 (1.2) | 1 (0.7) | 3 (2.1) |
|
| |||
| Coughing | 4 (2.4) | 2 (1.4) | 4 (2.7) |
|
| |||
| Pounding heart | 0 | 0 | 2 (1.4) |
|
| |||
| Diarrhead | 0 | 0 | 3 (2.1) |
|
| |||
| Insomnia | 7 (4.2) | 7 (4.7) | 4 (2.7) |
|
| |||
| Skin redness | 5 (3.0) | 5 (3.4) | 3 (2.1) |
|
| |||
| Dizziness | 0 | 1 (0.7) | 2 (1.4) |
|
| |||
| Light-headedness | 2 (1.2) | 1 (0.7) | 2 (1.4) |
|
| |||
| Sweating | 9 (5.5) | 4 (2.7) | 2 (1.4) |
|
| |||
| Watery eyes | 0 | 2 (1.4) | 0 |
|
| |||
| Coldness in hands or feet | 2 (1.2) | 0 | 0 |
|
| |||
| Disturbing dreams | 5 (3.0) | 5 (3.4) | 3 (2.1) |
|
| |||
| Vomiting | 1 (0.6) | 0 | 1 (0.7) |
|
| |||
| Shortness of breath | 3 (1.8) | 1 (0.7) | 1 (0.7) |
|
| |||
| Rapid heart beat | 1 (0.6) | 0 | 2 (1.4) |
|
| |||
| Week 12 Adverse Effects | |||
|
| |||
| No. of participants | 128 | 137 | 121 |
|
| |||
| Summary score, mean (SD)c | 4.1 (5.1) | 3.6 (4.7) | 3.9 (4.4) |
|
| |||
| Frequency of severe adverse effects | 13 (10.2) | 9 (6.6) | 11 (9.1) |
|
| |||
| Headache | 1 (0.8) | 0 | 3 (2.5) |
|
| |||
| Nausea | 1 (0.8) | 0 | 1 (0.8) |
|
| |||
| Coughing | 4 (3.1) | 2 (1.5) | 2 (1.7) |
|
| |||
| Pounding heart | 0 | 1 (0.7) | 1 (0.8) |
|
| |||
| Diarrhea | 2 (1.6) | 0 | 0 |
|
| |||
| Insomnia | 6 (4.7) | 4 (2.9) | 4 (3.3) |
|
| |||
| Skin redness | 1 (0.8) | 1 (0.7) | 0 |
|
| |||
| Dizziness | 0 | 0 | 1 (0.8) |
|
| |||
| Light-headedness | 0 | 0 | 0 |
|
| |||
| Sweating | 1 (0.8) | 0 | 0 |
|
| |||
| Watery eyes | 2 (1.6) | 2 (1.5) | 1 (0.8) |
|
| |||
| Coldness in hands or feet | 1 (0.8) | 0 | 1 (0.8) |
|
| |||
| Disturbing dreams | 1 (0.8) | 1 (0.7) | 4 (3.3) |
|
| |||
| Vomiting | 1 (0.8) | 0 | 0 |
|
| |||
| Shortness of breath | 0 | 1 (0.7) | 1 (0.7) |
|
| |||
| Rapid heart beat | 0 | 0 | 2 (1.7) |
|
| |||
| Week 30 Adverse Effects | |||
|
| |||
| No. of participants | 103 | 116 | 103 |
|
| |||
| Summary score, mean (SD)c | 3.7 (5.5) | 2.7 (4.1) | 3.3 (3.8) |
|
| |||
| Frequency of severe adverse effects | 5 (4.9) | 3 (2.6) | 7 (6.8) |
|
| |||
| Headache | 1 (1.0) | 0 | 0 |
|
| |||
| Nausea | 0 | 0 | 1 (1.0) |
|
| |||
| Coughing | 1 (1.0) | 1 (0.9) | 0 |
|
| |||
| Pounding heart | 2 (1.9) | 1 (0.9) | 1 (1.0) |
|
| |||
| Diarrhea | 0 | 0 | 1 (1.0) |
|
| |||
| Insomnia | 2 (1.9) | 2 (1.7) | 0 |
|
| |||
| Skin redness | 0 | 0 | 2 (1.9) |
|
| |||
| Dizziness | 0 | 0 | 0 |
|
| |||
| Light-headedness | 0 | 0 | 0 |
|
| |||
| Sweating | 1 (1.0) | 1 (0.9) | 0 |
|
| |||
| Watery eyes | 2 (1.9) | 1 (0.9) | 2 (1.9) |
|
| |||
| Coldness in hands or feet | 1 (1.0) | 0 | 0 |
|
| |||
| Disturbing dreams | 0 | 1 (0.9) | 1 (0.9) |
|
| |||
| Vomiting | 0 | 0 | 0 |
|
| |||
| Shortness of breath | 1 (1.0) | 0 | 0 |
|
| |||
| Rapid heart beat | 1 (1.0) | 1 (0.9) | 0 |
a
Unless otherwise indicated, data are expressed as number (percentage) of participants.
b
Self-reported by participants during the trial (standard treatment arm: cancer, kidney stones, pneumonia, and death [withdrawn]; extended treatment arm: cysts and cancer; maintenance treatment arm: infection, kidney disease, pericarditis, hypertension [withdrawn], chronic obstructive pulmonary disease, dehydration, abdominal pain, and death [withdrawn]).
c
Indicates the mean total score on all adverse effect checklist items; individual adverse effects are noted only if considered severe.
d
Comparison across treatment arm is significant (P < .05).