This work is licensed under a The authors and journal apologise for an error in the above paper, which appeared in volume 14, part 9, article ID e250493. The error relates to Table 4, given on pages 9 and 10, in which the n value of the ‘Age ≥2 years’ group was given as n = 22,976, when this should have been n = 21,976. The Table 4 associated with the version of record has been corrected.
The corrected Table 4 is given in full below:
Table 4.
Summary of AEs (NSARs, SARs, and SAEs) by system organ class in children included in the NordiNet® IOS and ANSWER program studies, according to the age at growth hormone treatment initiation.
| System organ class | Total events, n | Age <2 years | Age ≥2 years | ||||
|---|---|---|---|---|---|---|---|
| n = 882* | n = 21,976* | ||||||
| IGHD (n = 592) | MPHD (n = 290) | ||||||
| Events, n | Patients, n (%) | Events, n | Patients, n (%) | Events, n | Patients, n (%) | ||
| Nervous system disorders | 208 | 2 | 2 (0.34) | 7 | 5 (1.72)† | 199 | 163 (0.74) |
| Seizure | 31 | 2 | 2 (0.34) | 3 | 3 (1.03) | 26 | 14 (0.06) |
| Febrile convulsion | 2 | – | – | 1 | 1 (0.34) | 1 | 1 (<0.01) |
| Generalised tonic–clonic seizure | 4 | – | – | 1 | 1 (0.34) | 3 | 2 (<0.01) |
| Hypoglycaemic seizure | 2 | – | – | 2 | 2 (0.69) | – | – |
| Musculoskeletal and connective tissue disorders | 155 | 2 | 2 (0.34) | 3 | 3 (1.03) | 150 | 126 (0.57) |
| Epiphysiolysis | 9 | – | – | 2 | 2 (0.69) | 7 | 7 (0.03) |
| Myalgia | 16 | – | – | 1 | 1 (0.34) | 15 | 15 (0.06) |
| General disorders and administration-site conditions | 98 | 3 | 3 (0.51) | 8 | 6 (2.07) | 87 | 79 (0.36) |
| Hyperthermia | 3 | – | – | 3 | 2 (0.69) | – | – |
| Hypothermia | 1 | – | – | 1 | 1 (0.34) | – | – |
| Pyrexia | 3 | 1 | 1 (0.17) | 1 | 1 (0.34) | 2 | 2 (<0.01) |
| Injection site atrophy | 4 | – | – | 1 | 1 (0.34) | 3 | 3 (0.01) |
| Oedema | 8 | – | – | 1 | 1 (0.34) | 7 | 6 (0.03) |
| Infections and infestations | 55 | 3 | 3 (0.51) | 16 | 12 (4.14) | 36 | 28 (0.13) |
| Gastroenteritis | 7 | 1 | 1 (0.17) | 4 | 4 (1.38) | 2 | 2 (<0.01) |
| Gastroenteritis norovirus | 1 | – | – | 1 | 1 (0.34) | – | – |
| Gastroenteritis rotavirus | 1 | – | – | 1 | 1 (0.34) | – | – |
| Gastroenteritis viral | 2 | – | – | 1 | 1 (0.34) | 1 | 1 (<0.01) |
| Cellulitis orbital | 1 | – | – | 1 | 1 (0.34) | – | – |
| Infection | 2 | – | – | 1 | 1 (0.34) | 1 | 1 (<0.01) |
| Influenza | 1 | – | – | 1 | 1 (0.34) | – | – |
| Meningitis pneumococcal | 1 | – | – | 1 | 1 (0.34) | – | – |
| Otitis media | 2 | – | – | 1 | 1 (0.34) | 1 | 1 (<0.01) |
| Pneumonia | 9 | – | – | 1 | 1 (0.34) | 8 | 7 (0.03) |
| Pyelonephritis | 1 | – | – | 1 | 1 (0.34) | – | – |
| Respiratory syncytial virus bronchitis | 1 | – | – | 1 | 1 (0.34) | – | – |
| Viral upper respiratory tract infection | 2 | – | – | 1 | 1 (0.34) | 1 | 1 (<0.01) |
| Neoplasms benign, malignant, and unspecified (incl. cysts and polyps) | 50 | 1 | 1 (0.17) | 0 | 0 | 49 | 43 (0.20) |
| Gastrointestinal disorders | 32 | 2 | 1 (0.17) | 5 | 5 (1.72) | 25 | 20 (0.09) |
| Abdominal pain | 2 | – | – | 1 | 1 (0.34) | 1 | 1 (<0.01) |
| Inguinal hernia | 2 | – | – | 1 | 1 (0.34) | 1 | 1 (<0.01) |
| Stomatitis | 1 | – | – | 1 | 1 (0.34) | – | – |
| Vomiting | 10 | 1 | 1 (0.17) | 2 | 2 (0.69) | 7 | 7 (0.03) |
| Metabolism and nutrition disorders | 32 | 0 | 0 | 4 | 4 (1.38) | 28 | 25 (0.11) |
| Hypoglycaemia | 3 | – | – | 3 | 3 (1.03) | – | – |
| Lack of satiety | 1 | – | – | 1 | 1 (0.34) | – | – |
| Injury, poisoning, and procedural complications | 27 | 1 | 1 (0.17) | 1 | 1 (0.34) | 25 | 20 (0.09) |
| Skin and subcutaneous tissue disorders | 23 | 0 | 0 | 2 | 2 (0.69) | 21 | 20 (0.09) |
| Psychiatric disorders | 19 | 6 | 1 (0.17) | 0 | 0 | 13 | 11 (0.05) |
| Investigations | 17 | 1 | 1 (0.17) | 3 | 3 (1.03) | 13 | 11 (0.05) |
| Respiratory, thoracic, and mediastinal disorders | 13 | 1 | 1 (0.17) | 1 | 1 (0.34) | 11 | 9 (0.04) |
| Endocrine disorders | 11 | 1 | 1 (0.17) | 0 | 0 | 10 | 9 (0.04) |
| Surgical and medical procedures | 11 | 1 | 1 (0.17) | 2 | 1 (0.34) | 8 | 8 (0.04) |
| Congenital, familial, and genetic disorders | 9 | 0 | 0 | 1 | 1 (0.34) | 8 | 7 (0.03) |
| Eye disorders | 8 | 0 | 0 (0) | 0 | 0 (0) | 8 | 8 (0.04) |
| Renal and urinary disorders | 8 | 0 | 0 (0) | 1 | 1 (0.34) | 7 | 7 (0.03) |
| Cardiac disorders | 5 | 0 | 0 (0) | 1 | 1 (0.34) | 4 | 4 (0.02) |
| Hepatobiliary disorders | 4 | 1 | 1 (0.17) | 0 | 0 | 3 | 3 (0.01) |
| Reproductive system and breast disorders | 4 | 0 | 0 (0) | 0 | 0 (0) | 4 | 4 (0.02) |
| Immune system disorders | 3 | 0 | 0 (0) | 0 | 0 (0) | 3 | 3 (0.01) |
| Vascular disorders | 3 | 0 | 0 (0) | 0 | 0 (0) | 3 | 3 (0.01) |
| Blood and lymphatic system disorders | 2 | 0 | 0 (0) | 0 | 0 (0) | 2 | 2 (0.01) |
| Ear and labyrinth disorders | 2 | 0 | 0 (0) | 0 | 0 (0) | 2 | 2 (0.01) |
| Social circumstances | 1 | 0 | 0 (0) | 0 | 0 (0) | 1 | 1 (0.01) |
IGHD, isolated growth hormone deficiency; IOS, International Outcome Study; MPHD, multiple pituitary hormone deficiency; NSARs, non-serious adverse reactions; SAEs, serious adverse events; SARs, serious adverse reactions; SAS, safety analysis set.
The breakdown of specific NSARs, SAEs, and SARs occurring in >1.0% of participants is presented.
Patients in each group for the SAS.
Bold values highlight findings for main system organ classes with listed subcategories for children with MPHD.