Table 2.
– Adverse events and serious adverse events relating to diabetes mellitus
| MedDRA PT (AE/SAE) | Indication and GHD onset, pretreatment status | Body weight at baseline (kg) | HbA1c at baseline (%) | Dose at AE onseta (mg/day) | Time to AE/SAE onsetb (day) | BMI at AE onset (kg/m2) | Intensity | Causalityc | Outcome | Treatment with Omnitrope® | Relevant medical history; Concomitant medication; Cardiovascular AE (Y if reported) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Diabetes mellitus (AE) | MPHD in childhood, pretreated | 125.6 | 6.00 | 0.40 | 398 | 41.9 | NR | Not suspected | Ongoing | Not changed | None |
| Diabetes mellitus (AE) | Isolated GHD in adulthood, naïve | 67.4 | 6.08 | 0.20 | 694 | 28.1 | Moderate | Not suspected | Ongoing | Not changed | None |
| Diabetes mellitus (SAE) | MPHD in adulthood, naïve | 131.0 | 5.00 | 0.40 | 608 | 42.8 | Moderate | Not suspected | Ongoing | Not changed | None; Hydrocortisone, statin |
| Diabetes mellitus inadequate control (AE) | MPHD in adulthood, naïve | 131.0 | 5.00 | 0.40 | 2338 | 46.7 | NR | Not suspected | Ongoing | Not changed | None; Hydrocortisone, statin |
| Diabetes mellitus [verbatim; worsening of diabetes] (SAE) | MPHD in adulthood, naïve | 92.9 | NR | 0.20 | 127 | 29.3 | Mild | Suspected | Ongoing | Permanently discontinued | Diabetes mellitus |
| Diabetes mellitus [verbatim; worsening of diabetes] (SAE) | MPHD in adulthood, pretreated | 63.6 | 10.11 | 0.10 | 1 | 25.2 | Mild | Suspected | Ongoing | Interrupted | Type 2 diabetes mellitus; Hydrocortisone, statin |
| Diabetes mellitus inadequate control (AE) | MPHD in adulthood, naïve | 107.2 | 6.90 | 0.20 | 168 | 38.0 | Mild | Not suspected | Ongoing | Not changed | Type 2 diabetes mellitus; Hydrocortisone, statin |
| Diabetes mellitus type 2 inadequate control (AE) | MPHD in adulthood, naïve | 74.3 | 8.92 | NR | NR | NR | Moderate | Not suspected | Ongoing | Not changed | Type 2 diabetes mellitus; Hydrocortisone, statin |
| Type 2 diabetes mellitus (AE) | MPHD in adulthood, naïve | 107.6 | 6.00 | 0.15 | 841 | 39.6 | Mild | Not suspected | Ongoing | Not changed | None; Hydrocortisone, statin |
| Type 2 diabetes mellitus (AE) | MPHD in adulthood, pretreated | 99.7 | 6.18 | 0.50 | 1041 | 33.4 | Moderate | Not suspected | Ongoing | Not changed | Cushing’s syndrome; Statin; Y |
| Type 2 diabetes mellitus (AE) | MPHD in adulthood, pretreated | 95.8 | NR | 0.15 | 1130 | 37.9 | Mild | Not suspected | Ongoing | Not changed | None; Hydrocortisone |
| Type 2 diabetes mellitus (AE) | MPHD in adulthood, pretreated | 123.9 | 6.70 | 0.50 | 372 | 51.6 | Mild | Not suspected | Ongoing | Not changed | Diabetes mellitus; Cushing’s syndrome; hydrocortisone |
| Type 2 diabetes mellitus (AE) | MPHD in adulthood, naïve | 90.0 | 6.30 | 0.20 | 360 | 37.5 | Mild | Not suspected | Ongoing | Not changed | Type 2 diabetes mellitus |
| Type 2 diabetes mellitus (AE) | MPHD in adulthood, naïve | 111.3 | 6.00 | 0.14 | 650 | 36.2 | Mild | Not suspected | Resolved completely | Not changed | None; Cortisone acetate, statin |
| Type 2 diabetes mellitus (AE) | MPHD in adulthood, pretreated | 94.0 | NR | 0.50 | 998 | 27.8 | Mild | Not suspected | Ongoing | Not changed | None |
| Type 2 diabetes mellitus (SAE) | MPHD in adulthood, pretreated | 108.1 | 5.90 | 0.30 | 955 | 43.2 | Mild | Not suspected | Ongoing | Not changed | None; Hydrocortisone, statin |
| Type 2 diabetes mellitus (SAE) | MPHD in adulthood, pretreated | 104.6 | NR | NR | NR | NR | Mild | Not suspected | Ongoing | Not changed | None; Hydrocortisone |
| Type 2 diabetes mellitus (SAE) | MPHD in adulthood, naïve | 106.7 | NR | 0.30 | 9 | 39.2 | Mild | Not suspected | Ongoing | Not changed | None; Statin |
| Type 2 diabetes mellitus (SAE) | MPHD in adulthood, naïve | 105.0 | 5.99 | 0.40 | 521 | 32.3 | Mild | Not suspected | Ongoing | Not changed | None; Hydrocortisone, statin |
| Type 2 diabetes mellitus (SAE) | MPHD in adulthood, pretreated | 63.7 | 5.90 | 0.20 | 1274 | 26.1 | Moderate | Not suspected | Ongoing | Not changed | None; Hydrocortisone, statin; Y |
| Type 2 diabetes mellitus (SAE) | MPHD in adulthood, naïve | 95.0 | NR | 0.36 | 1317 | 32.5 | Mild | Not suspected | Ongoing | Not changed | None; Cortisone acetate, statin; Y |
| Type 2 diabetes mellitus (SAE) | MPHD in adulthood, naïve | 100.0 | 6.91 | 0.30 | 260 | 33.8 | Mild | Not suspected | Ongoing | Not changed | None; Hydrocortisone |
aLast documented dose before AE onset in mg/day; bTime to SAE onset after start of Omnitrope® treatment; cAssessment of relationship to study drug according to Investigator and Sponsor (worst case)
AE adverse event; BMI body mass index; GHD growth hormone deficiency; HbA1c glycated hemoglobin; MedDRA Medical Dictionary for Regulatory Activities; MPHD multiple pituitary hormone deficiency; NR not recorded; PT Preferred Term; SAE serious adverse event; Y Yes