Table 5.
Frequently reported TEAEs (≥3% of patients in ≥1 treatment arm) in parts 2 and 3
| Category of TEAE | Safety analysis set 2 during part 2 of the studya | Safety analysis set 2 during part 2 and/or part 3 of the studya | ||||
|---|---|---|---|---|---|---|
| CC (n = 53) |
LC (n = 51) |
LC (n = 52) |
||||
| n (%) | m | n (%) | m | n (%) | m | |
| Any | 28 (52.8) | 63 | 28 (54.9) | 56 | 41 (78.8) | 124 |
| Serious | 9 (17.0) | 10 | 11 (21.6) | 17 | 19 (36.5) | 29 |
| Related to study drug | 10 (18.9) | 16 | 8 (15.7) | 14 | 12 (23.1) | 21 |
| Leading to study withdrawal | 2 (3.8) | 2 | 3 (5.9) | 6 | 3 (5.8) | 6 |
| Leading to death | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 |
| TEAEs occurring in ≥3% of patients in ≥1 treatment arm | ||||||
| Blood and lymphatic system disorders | ||||||
| Anemia | 0 (0.0) | 0 | 0 (0.0) | 0 | 2 (3.8) | 2 |
| Gastrointestinal disorders | ||||||
| Vomitingb | 1 (1.9) | 2 | 2 (3.9) | 2 | 6 (11.5) | 7 |
| Nauseac | 2 (3.8) | 2 | 2 (3.9) | 3 | 4 (7.7) | 6 |
| Abdominal pain | 1 (1.9) | 1 | 0 (0.0) | 0 | 2 (3.8) | 3 |
| Diarrhea | 2 (3.8) | 3 | 0 (0.0) | 0 | 0 (0.0) | 0 |
| General disorders and administration site conditions | ||||||
| Pyrexia | 0 (0.0) | 0 | 1 (2.0) | 1 | 2 (3.8) | 3 |
| Infections and infestations | ||||||
| Peritonitisd | 0 (0.0) | 0 | 3 (5.9) | 4 | 5 (9.6) | 6 |
| Upper respiratory tract infection | 0 (0.0) | 0 | 3 (5.9) | 3 | 5 (9.6) | 5 |
| Nasopharyngitis | 2 (3.8) | 2 | 0 (0.0) | 0 | 2 (3.8) | 3 |
| Device related infection | 0 (0.0) | 0 | 2 (3.9) | 2 | 2 (3.8) | 3 |
| Respiratory tract infection | 3 (5.7) | 5 | 0 (0.0) | 0 | 2 (3.8) | 2 |
| Hordeolum | 0 (0.0) | 0 | 1 (2.0) | 1 | 2 (3.8) | 2 |
| Influenza | 2 (3.8) | 2 | 0 (0.0) | 0 | 1 (1.9) | 1 |
| Metabolism and nutrition disorders | ||||||
| Hypercalcemiae | 9 (17.0) | 9 | 4 (7.8) | 4 | 5 (9.6) | 9 |
| Hypocalcemia | 3 (5.7) | 3 | 1 (2.0) | 1 | 3 (5.8) | 6 |
| Hyperkalemiae | 1 (1.9) | 1 | 0 (0.0) | 0 | 2 (3.8) | 2 |
| Hyperphosphatemia | 2 (3.8) | 2 | 0 (0.0) | 0 | 0 (0.0) | 0 |
| Hypophosphatemia | 3 (5.7) | 4 | 4 (7.8) | 5 | 6 (11.5) | 10 |
| Vascular disorders | ||||||
| Hypotension | 0 (0.0) | 0 | 2 (3.9) | 4 | 2 (3.8) | 4 |
| Hypertensiond | 3 (5.7) | 3 | 1 (2.0) | 1 | 1 (1.9) | 1 |
Safety analysis set 2 included all patients who received at least one dose of CC or LC in part 2 and/or part 3 of the study and attended at least one follow-up visit. Reported TEAEs are stratified by treatment group and by system organ class and preferred term. Most TEAEs were considered by the investigator to be mild or moderate in severity, unless otherwise indicated
a TEAEs were categorized by the treatment most recently received by the patient and patients were counted once per category, per treatment group; adverse events were considered TEAEs if they occurred in the 3 weeks after the most recent dose of study drug within the relevant part of the study
b TEAEs were classified as severe in one LC-treated patient (2.0%) in part 2, and one LC-treated patient (1.9%) in parts 2 and 3 combined
c TEAEs were classified as severe in one LC-treated patient (2.0%) in part 2, and one LC-treated patient (1.9%) in parts 2 and 3 combined
d TEAEs were classified as severe in two LC-treated patients (3.9%) in part 2, and three LC-treated patients (5.8%) in parts 2 and 3 combined
e TEAEs were classified as severe in one CC-treated patient (1.9%) in part 2
CC calcium carbonate, LC lanthanum carbonate, m the number of events experienced, TEAE treatment-emergent adverse event